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SmartSupplies LRA

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SmartSupplies

SmartSupplies                             For More Information Click Here To send an email request.

SmartSupplies LRA is an easy to use, fully web enabled software solution that empowers pharmaceutical and biotechnology organizations of all sizes to effectively collaborate, organize, and control the clinical supplies labeling process.

SmartSupplies LRA provides a phrase and translation library to accurately record the phrases that are approved for use on clinical trial labels.  Import and approve translations and attach translation certificates directly within the phrase and translation library.  Each phrase can then be approved for a particular country or countries, ensuring regulatory compliance throughout your labeling process.

The SmartSupplies LRA solution increases staff efficiency by allowing you to build re-usable templates - automatically associating the country-specific phrases with each new template, and allowing the user to customize the phrases to be included or excluded from a particular type of label.

Phrases
Record and approve official phrase text
Record and approve translations for multiple languages
Attach translation certification documents
Associate phrases with countries for automatic inclusion in label templates
Label Templates
Design re-usable label templates
Automatic population of country-specific phrases
Fine-tune control for inclusion/exclusion of phrases
View included phrases by country and/or language
Attach layout drawings and/or vendor specifications
Label Specifications
Create label specifications from approved templates
Incorporate static or variable run-time text such as Study No. or Med ID
View phrases and translations as they will appear on the label, by country and/or language
View attachments carried forward from template and/or add new attachments
Approval Routing
Configure separate default routing groups/routing order for templates and specifications
Supports parallel, sequential, and combination parallel/sequential routing
Fine-tune routing configuration for a particular template/specification
Configurable e-mail notifications for each stage of the approval process
21 CFR Part 11 compliant audit trail and approval/rejection history
Allows reviewers to approve, reject, revert approval, or delegate approval to another qualified individual
Provides complete visibility of routing process


For More Information Click Here To send an email request.